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目的按照国家计划抽验要求,评价国内不同企业生产的注射用美罗培南的质量。方法按国家标准检验与探索性研究相结合,对抽验样品进行检验,对检验结果进行统计分析。结果共抽取样品115批次,按国家标准检验合格率99.1%,1批溶液的颜色不符合规定。探索性研究优化了现行标准有关物质检查方法,对主要杂质的来源与结构进行了研究;发现溶液的澄清度主要与样品的酸碱度和制剂规格有关;有关物质、色差值和聚合物均与碳酸钠含量呈显著正相关;美罗培南输液的配伍稳定性较差。结论目前国内注射用的美罗培南总体质量较好;现行标准有待进一步提高,建议现行标准修订有关物质检查方法,增加碳酸钠含量测定;建议企业优化处方配比,以提高产品质量。
Objective To evaluate the quality of Meropenem for injection produced by different domestic enterprises in accordance with the requirements of national plan sampling. Methods According to the combination of national standard test and exploratory test, the test sample is tested and the test results are statistically analyzed. Results A total of 115 batches of samples were taken and the pass rate of 99.1% was tested according to the national standard. The color of one batch of solution did not meet the requirements. Exploratory research optimized the existing standards related to material inspection methods, the source and structure of the major impurities were studied; the clarity of the solution was found to be mainly related to the pH and formulation specifications of the sample; related substances, color difference values, Sodium content was significantly positive correlation; Meropenem infusion incompatibility stability is poor. Conclusion At present, the overall quality of meropenem used for domestic injection is good. The current standards need to be further improved. It is suggested that the existing standards should be revised to check the contents of the substances and the content of sodium carbonate should be increased. It is suggested that enterprises should optimize the prescription ratio to improve product quality.